Method and apparatus for treating bone fractures, and/or for fortifying and/or augmenting bone, including the provision and use of composite implants, and novel composite structures which may be used for medical and non-medical applications

Abstract

A composite comprising: a barrier, said barrier being configured to selectively pass water, and said barrier being degradable in the presence of water; a matrix material for disposition within said barrier, wherein said matrix material has a flowable state and a set state, and wherein said matrix material is degradable in the presence of water; and at least one reinforcing element for disposition within said barrier and integration with said matrix material, wherein said at least one reinforcing element is degradable in the presence of water, and further wherein, upon the degradation of said at least one reinforcing element in the presence of water, provides an agent for modulating the degradation rate of said matrix material in the presence of water.

What is claimed is: 
     
         1 . An implant comprising:
 a core structure comprising:
 at least one reinforcement component in the form of a rod, wherein the rod reinforcement component comprises a thermoplastic matrix and a plurality of fibers disposed within the thermoplastic matrix; and 
 at least one reinforcement component in the form of a sheet, wherein the sheet reinforcement component comprises a thermoplastic matrix and a plurality of fibers disposed within the thermoplastic matrix; 
 wherein the at least one rod reinforcement component and the at least one sheet reinforcement component are secured to one another so as to form the core structure. 
   
     
     
         2 . An implant according to  claim 1  wherein the thermoplastic matrix of the rod reinforcement component comprises PLDLA, and the thermoplastic matrix of the sheet reinforcement component comprises PLDLA. 
     
     
         3 . An implant according to  claim 1  wherein the fibers of the rod reinforcement component are intertwined with one another. 
     
     
         4 . An implant according to  claim 1  wherein the fibers of the sheet reinforcement component extend substantially parallel to one another. 
     
     
         5 . An implant according to  claim 1  wherein the fibers of the sheet reinforcement component extend substantially transverse to one another. 
     
     
         6 . An implant according to  claim 1  wherein the fibers of the rod reinforcement component comprise a surface coating for improving integration of the fibers with the thermoplastic matrix of the rod reinforcement component, and the fibers of the sheet reinforcement component comprise a surface coating for improving integration of the fibers with the thermoplastic matrix of the sheet reinforcement component. 
     
     
         7 . An implant according to  claim 1  wherein the fibers of the rod reinforcement component comprise silicate glass fibers, and the fibers of the sheet reinforcement component comprise silicate glass fibers. 
     
     
         8 . An implant according to  claim 1  wherein at least one rod reinforcement component is encased by at least one sheet reinforcement component. 
     
     
         9 . An implant according to  claim 8  wherein a plurality of rod reinforcement components are encased by at least one sheet reinforcement component. 
     
     
         10 . An implant according to  claim 9  wherein the cross-sectional profile of the core structure is determined by the number and disposition of the rod reinforcement components. 
     
     
         11 . An implant according to  claim 8  wherein the at least one rod reinforcement component is encased by a plurality of sheet reinforcement components. 
     
     
         12 . An implant according to  claim 11  wherein the plurality of sheet reinforcement components are arranged in layers over the at least one rod reinforcement component. 
     
     
         13 . An implant according to  claim 12  wherein the layers of sheet reinforcement components are arranged so that at least some of the fibers of one layer are transverse to at least some of the fibers of another layer. 
     
     
         14 . An implant according to  claim 1  wherein the implant comprises a shaft, and further wherein the core forms the shaft of the implant. 
     
     
         15 . An implant according to  claim 14  wherein a surface layer is added to the core to provide desired surface characteristics. 
     
     
         16 . An implant according to  claim 15  wherein the surface layer is added to the core to modulate the passage of body fluids through the surface layer. 
     
     
         17 . An implant according to  claim 15  wherein the surface layer is added to the core to provide surface features to the core. 
     
     
         18 . An implant according to  claim 17  wherein the surface features comprise screw threads. 
     
     
         19 . An implant according to  claim 14  wherein the implant comprises one of the group consisting of a pin, a screw and a rod. 
     
     
         20 . An implant according to  claim 1  wherein the implant further comprises a bag, and further wherein at least one core is inserted into the bag, and thermoset material is inserted into the bag. 
     
     
         21 . An implant according to  claim 20  wherein the at least one core comprises a coating for integrating with the thermoset material. 
     
     
         22 . An implant according to  claim 20  wherein the bag modulates the passage of body fluids through the bag. 
     
     
         23 . An implant according to  claim 20  wherein degradation of the at least one core releases agents for degrading the thermoset material. 
     
     
         24 . An implant according to  claim 20  wherein the thermoset material comprises polyurethane. 
     
     
         25 . An implant comprising:
 a core structure comprising:
 a plurality of reinforcement components each in the form of a sheet, wherein each sheet reinforcement component comprises a thermoplastic matrix and a plurality of fibers disposed within the thermoplastic matrix; and 
 wherein the plurality of sheet reinforcement components are arranged in layers so as to form the core structure, and further wherein the layers of sheet reinforcement components are arranged so that at least some of the fibers of one layer are transverse to at least some of the fibers of another layer. 
   
     
     
         26 . An implant comprising:
 a core structure comprising:
 at least one reinforcement component in the form of a rod, wherein the rod reinforcement component comprises a thermoplastic matrix and a plurality of fibers disposed within the thermoplastic matrix; and 
 wherein the fibers of the rod reinforcement component are intertwined with one another. 
   
     
     
         27 . A composite comprising:
 a barrier, said barrier being configured to selectively pass water, and said barrier being degradable in the presence of water;   a matrix material for disposition within said barrier, wherein said matrix material has a flowable state and a set state, and wherein said matrix material is degradable in the presence of water; and   at least one reinforcing element for disposition within said barrier and integration with said matrix material, wherein said at least one reinforcing element is degradable in the presence of water, and further wherein, upon the degradation of said at least one reinforcing element in the presence of water, provides an agent for modulating the degradation rate of said matrix material in the presence of water;   wherein the at least one reinforcement element comprises a plurality of soluble glass fibers, wherein each of said plurality of soluble glass fibers comprises a solubility gradient profile ranging from 100% of the solubility of the initial glass to a surface-modified solubility of less than the solubility of the initial glass.   
     
     
         28 . A composite according to  claim 27  wherein the solubility gradient profile of each of said plurality of soluble glass fibers is independently adjustable. 
     
     
         29 . A composite implant according to  claim 27  wherein the soluble glass fibers comprise a plurality of soluble layers, and further wherein each of the soluble layers can be configured to solubilize at a different rate. 
     
     
         30 . A composite comprising:
 at least one reinforcing element, wherein said at least one reinforcing element comprises at least one soluble glass fiber, and further wherein said at least one soluble glass fiber is degradable in the presence of water and comprises a surface-modified solubility which is different than the solubility of the remainder of said at least one soluble glass fiber; and   a matrix material for disposition around said at least one reinforcing element, wherein said matrix material has a flowable state and a set state, and wherein said matrix material is degradable in the presence of water.   
     
     
         31 . A composite according to  claim 30  wherein said at least one soluble glass fiber is 100% soluble. 
     
     
         32 . A composite according to  claim 30  wherein said at least one soluble glass fiber comprises a plurality of soluble layers. 
     
     
         33 . A composite according to  claim 32  wherein each of said soluble layers is configured to solubilize at a different rate. 
     
     
         34 . A composite comprising:
 at least one reinforcing element, wherein said at least one reinforcing element comprises at least one soluble glass fiber, and further wherein said at least one soluble glass fiber is degradable in the presence of water and comprises an independently-adjustable solubility gradient profile; and   a matrix material for disposition around said at least one reinforcing element, wherein said matrix material has a flowable state and a set state, and wherein said matrix material is degradable in the presence of water.   
     
     
         35 . A composite according to  claim 34  wherein said at least one soluble glass fiber comprises a surface modification which modifies the mechanical properties or chemical properties of the at least one soluble glass fiber. 
     
     
         36 . A composite according to  claim 34  wherein said at least one soluble glass fiber comprises a plurality of layers. 
     
     
         37 . A composite according to  claim 36  wherein each of said plurality of layers is configured to solubilize at a different rate. 
     
     
         38 . A composite comprising a polymer comprising a blend of (i) one or more reactants with at least two functional groups, (ii) a low molecular weight functional modifier, and (iii) a poly functional aliphatic or cycloaliphatic isocyanate crosslinker;
 wherein said one or more reactants with at least two functional groups comprises one selected from the group consisting of (a) hydroxyl functional reaction products of a C2 to C16 aliphatic or cycloaliphatic or heterocyclic diols or triols or blends of these polyols with a saturated or unsaturated C2 to C36 aliphatic dicarboxylic or tricarboxylic acid, anhydrides or lactones and/or lactides and/or glycolides and/or carbonates or blends of these carboxylic acids, (b) amine functional aspartic acid ester, (c) CH— active compounds, and (d) blends of the foregoing.   
     
     
         39 . A composite according to  claim 38  wherein said low molecular weight functional modifier comprises an aliphatic or cycloaliphatic or heterocyclic diol with C2 to C12 carbons. 
     
     
         40 . A composite according to  claim 38  wherein said poly functional aliphatic or cycloaliphatic isocyanate crosslinker comprises one selected from the group consisting of an isocyanurate (trimer), iminooxadiazine dione (asymmetric trimer), biuret, allophanate or uretdione (dimer) derivative (with an average functionality of between 2.0 to 4) of an C4 to C15 aliphatic or cycloaliphatic diisocyanate or lysine diisocyanate, a C4 to C15 aliphatic or cycloaliphatic diisocyanate or lysine diisocyanate. 
     
     
         41 . A composite according to  claim 38  wherein the crosslinked network has a crosslink density with an average molecular weight between crosslinks of less than 500, between 200 to 500, or greater than 250. 
     
     
         42 . A composite according to  claim 38  wherein said matrix material further comprises a catalyst. 
     
     
         43 . A composite according to  claim 42  wherein said catalyst comprises one selected from the group consisting of bismuth, potassium, aluminum, titanium, zirconium compounds or a t-amine, and organo-tin compounds. 
     
     
         44 . A composite according to  claim 38  wherein said composite consists of polyol and isocyanate precursors, with the polyol part having hydroxyl number of 150-750, and isocyanate part having isocyanate index of 0-15%, 15% to 45% or higher.